Universal cable connector for temporarily connecting implantable stimulation leads and implantable stimulation devices with a non-implantable system analyzer

ABSTRACT

A universal cable connector for use between an external system analyzer (54) and an implantable stimulation device includes a multi-conductor cable (60) and a universal connector block (52) having plurality of different sized female connectors adapted to mate with the proximal connectors of different sized implantable pacing leads (33, 34 or 38) and defibrillation leads (48, 50). The universal connector block (52) attaches to the system analyzer and enables the system analyzer to interface with whatever implantable stimulation leads are connected to the connector block, thereby allowing the system analyzer to perform desired tests, such as threshold-determining tests, using the implanted stimulation leads. An adapter cable (96) and clamp (94) are also provided that allow an electrical connection of the proper polarity to be established between an implantable stimulation device (24), e.g., an implantable cardioverter-defibrillator (ICD), and the universal connector block while the implantable stimulation device is connected to a patient via shocking leads (e.g., 48 and 50) and is operating, thereby permitting the system analyzer to monitor the performance of the implantable stimulation device.

CROSS REFERENCE

This is a divisional application of copending application Ser. No.08/223,567 (filed on Apr. 6, 1994), now U.S. Pat. No. 5,557,210 (issuedSep. 17, 1996), which is a continuation-in-part of prior co-pendingapplication Ser. No. 07/979,568 (filed on Nov. 20, 1992), now U.S. Pat.No. 5,334,045 (issued Apr. 15, 1994).

FIELD OF THE INVENTION

The present invention relates to implantable stimulation devices, suchas an implantable pacemaker or an implantable cardioverter/defibrillator(ICD). More particularly, the present invention relates to a universalcable connector that permits a system analyzer, used during an implantoperation, to perform various tests (e.g., threshold-determining tests)on a set of implanted stimulation leads and on an implantablestimulation device. The invention also permits an implantablestimulation device, while connected to a patient via a set of implantedstimulation leads, to be connected to the system analyzer through thecable connector.

BACKGROUND OF THE INVENTION

Most implantable stimulation devices, such as pacemakers and ICDs, useone or more implantable stimulation leads that electrically connect thestimulation device to a desired body tissue location. There are numeroustypes of implantable stimulation leads, just as there are numerous typesof implantable stimulation devices. Implantable stimulation leadsinclude sensing/pacing leads, shocking leads, epicardial leads,endocardial leads, atrial leads, ventricular leads, unipolar leads,bipolar leads, and the like. Representative of the many and varied typesof leads that exist are those described, e.g., in U.S. Pat. Nos.4,522,212; 4,649,938; 4,791,935; and 4,815,469; or as described byFurman, et. al, A Practice of Cardiac Pacing (Futura Pub. Co., Mt.Kisco, N.Y. 1986), e.g., at pp. 36-41.

All implantable stimulation leads include one or more electrodes at adistal end of the lead, and an electrical connector at a proximal end ofthe lead. The distal electrode is adapted to physically and/orelectrically contact body tissue at a desired monitoring and/orstimulating location. Active or passive fixation means may also beincluded as part of the lead at or near the distal end in order tosecure the electrode in its desired tissue-contacting location. Theproximal connector is adapted to interface with the implantablestimulation device. Connecting the distal electrode to the proximalconnector is the lead body. The lead body comprises one or more flexibleelectrical conductors, surrounded or otherwise protected by anappropriate insulating sheath, which establishes electrical connectionbetween the distal electrode and the proximal connector. (Note: As usedherein, and as is conventional when describing implantable stimulationleads, the "distal" end of a lead is the end farthest from thestimulation device, and the "proximal" end is the end closest to-usually the end connected to-the stimulation device.)

When an implantable stimulation lead is first implanted in a patient,there are some preliminary electrical tests that should be performedbefore the lead is finally attached to its corresponding stimulationdevice. For example, if the lead is a pacing lead that is to beconnected to an implantable pacemaker, then the lead is first implanted(e.g., transvenously) so that the distal electrode is in electricalcontact with cardiac muscle tissue. Then, before the proximal connectorof the lead is secured to the pacemaker, the proximal connector istemporarily connected to an appropriate testing device (e.g., a pacingsystem analyzer) so that a series of stimulation pulses of varyingenergies, or other test signals (such as signals to measure the leadimpedance), can be applied to the cardiac tissue through the lead inorder to ascertain the capture threshold at which the cardiac muscletissue contracts, or in order to determine other parameters associatedwith the lead. The results of such capture threshold testing, or othertesting, advantageously provide an indication as to whether the distalelectrode is making good contact with the body tissue, as well as whatthe initial setting of the stimulation energy of the pacemaker shouldbe.

If the lead is a shocking lead, also referred to as a defibrillationlead, then typically at least two shocking leads are implanted so thatthe distal electrodes contact the appropriate cardiac tissue. The distalelectrodes may comprise patch electrodes or any other appropriateshocking electrodes as disclosed, e.g., in U.S. Pat. Nos. 4,774,952;4,817,634; 4,865,037; 4,991,603; or 4,998,975. The proximal connectorsof such leads are then temporarily connected to an appropriate testingdevice, typically referred to as a "defibrillation system analyzer(DSA)".

The defibrillation system analyzer applies an appropriate signal(usually a low amplitude AC signal) to the shocking electrodes in orderto induce fibrillation. Shocking pulses of varying energies are thenapplied to the cardiac tissue across the shocking electrodes in order toascertain the defibrillation threshold, i.e., the amount of energyrequired in a defibrillation shock pulse in order to defibrillate theheart. Such defibrillation threshold is then used to guide the initialsetting of the defibrillation energy generated by the ICD.

Although the present invention is directed primarily towards a universalcable connector for temporarily connecting implantable shocking leadsand implantable shocking devices with a defibrillation system analyzer,it may be appreciated that the present invention may also be used withimplantable pacing leads, an implantable pacemaker and a "pacing systemanalyzer (PSA)" (i.e., a system analyzer which is used to test animplantable pacemaker). Thus, it shall be understood that "implantablestimulation leads" shall include both pacing and shocking leads,"implantable stimulation device" shall include both pacing and shockingdevices, and "system analyzers" shall include both pacing anddefibrillation system analyzers.

Proximal connectors used with most implantable stimulation leads aretypically one of two types: unipolar or bipolar. Unipolar proximalconnectors include a single proximal tip electrode (male connector)adapted to be inserted into an appropriate conductive annular ring orother receiving receptacle (female connector) located on or in theimplantable stimulation device. Secure physical and electrical contactbetween the male and female connectors is typically obtained using asetscrew. That is, the setscrew is threadably mounted in the femaleconnector and is tightened against the male connector so as to firmlyhold it in physical and electrical contact with the female connector. Inorder for a proper connection to be made, it is necessary that the maleconnector and female connectors be of the same size.

Bipolar proximal connectors typically include a proximal tip electrodethe same as is used in proximal unipolar connectors, and also include aproximal ring electrode, that is an annular conductive ring that isspaced-apart from the tip electrode. The receiving, or female bipolar,connector thus comprises an appropriate receiving channel havingseparate conductive elements therein that establish a secure physicaland electrical connection with the proximal tip and ring electrodes ofthe lead. A setscrew, or equivalent, may also be used to secure one orboth of the tip and ring electrodes within the female connector.

Some effort has been made in recent years to standardize the size ofproximal connectors used with pacing leads, see, e.g., Calfee et al., "AVoluntary Standard for 3.2 mm Unipolar and Bipolar Pacemaker Leads andConnectors," Pace, Vol. 9, pp. 1181-85, incorporated herein byreference. However, there still exists a wide variety of different sizesand types of proximal connectors that are used with implantablestimulation devices. Further, the size of proximal connectors used withshocking leads is typically different than the size of proximalconnectors used with sensing/pacing leads. Hence, in order to connectthe different sized proximal connectors to a system analyzer (orequivalent testing device) during the implant procedure, it hasheretofore been necessary to use a plurality of cables, connectorblocks, and/or a plurality of lead adapters for each size or type ofproximal connector that may be encountered. See, e.g., U.S. Pat. No.4,466,441 (in-line lead adapter).

Connection of implanted stimulation leads to a system analyzer in theprior art typically consists of two sets of cables and connector blocks;one for shocking and one for pacing functions. Each connector block ofthe prior art typically includes two female connectors to which twocorresponding proximal male connectors of the implanted stimulationleads may be temporarily attached. Such temporary attachment istypically achieved by using setscrew connectors mounted to the connectorblock that receive and grip the male tips of the implanted leads. Acable, usually hard-wired to the connectors at one end and having amulti-pin connector at the other end, then provides the appropriateelectrical interface between the connectors and the system analyzer.Unfortunately, the connectors used on such adapters are stillsize-dependent (i.e., there is no single female connector to which allsizes of proximal lead male connectors can be safely connected). Hence,different lead adapters must still be used for different sized leads.Thus, a substantial inventory of lead adapters must be maintained foruse in the operating room where the implant procedure is being carriedout. Further, any such adapters which are used must be sterile, whichrequires a separate sterilizing operation. Moreover, the use of suchadapters increases the risk of damage and/or connection error. That is,the frequent connecting and disconnecting of the proximal connectors toand from the setscrew or other female connectors of the lead adapters,can, if not carefully carried out, damage the proximal connectors,particularly the delicate proximal ring electrode, thereby rendering theimplanted lead unsuitable. Further, there is always the chance whenleads are frequently disconnected and re-connected that an error willoccur in the polarity of the connections that are made.

Hence, there is a need in the art for a way to safely and efficientlyconnect the various sizes and types of proximal connectors existing onimplanted stimulation leads to a system analyzer (or other testingdevice) used during the implant procedure, without the need ofmaintaining a large inventory of sterile lead adapters. That is, thereis a need for a universal connector that can be used with all implantedleads.

Further, it is desirable to test the performance of the implantablestimulation device prior to finalizing, its implantation, i.e., prior tosewing up the patient at the conclusion of the implant operation. Whenthe implantable stimulation device is an ICD, it is preferable that theICD be connected to the implanted leads at the same time that the systemanalyzer is connected to the ICD in order to monitor its performance,particularly to monitor the output energy delivered by the ICD.Typically, the state-of-the-art requires that such output energymonitoring can only be accomplished by using some sort of in-line leadadapter, e.g., a "Y" adapter that connects the output of the ICD to boththe implanted shocking leads and to the system analyzer. The use of suchadapter, which must be sterile, requires additional connecting anddisconnecting of the implanted lead, which additional connecting anddisconnecting may further damage the proximal male connector of the leador the corresponding female connector of the ICD. Further, suchadditional connecting also increases the possibility that a connectionof the incorrect polarity will be made. A connection of the improperpolarity could, where large shocking energies are used by an ICD, easilydamage the system analyzer and/or the ICD, and could be harmful to thepatient.

What is clearly needed, therefore, is a way to easily and safely testthe performance of the ICD, including testing the output energydelivered by the ICD, after the shocking leads have been implanted andconnected to the ICD. Accompanying this need is the need to perform suchtesting without the use of any special adapters that require additionaldisconnecting of the leads from the ICD and without the possibility ofmaking a mistake in the polarity of the connection.

Thus, in summary, to minimize the risk of lead damage or polarityconnection error, what is needed is an implant procedure or techniquewherein the implanted leads may be detachably connected to the systemanalyzer without using adapters or other holding mechanisms that coulddamage the leads; and wherein once the leads have been tested by thesystem analyzer, the leads may be connected to the ICD (or otherstimulation device) just once, yet that still allows the ICD to be fullytested after the leads have been so connected, including the testing ofthe output energy delivered by the ICD, without concern for whether aproper polarity has been achieved between the ICD and the systemanalyzer.

The present invention advantageously addresses the above and otherneeds.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present invention, there isprovided a sterilizable cable connector block that includes a pluralityof different sized connectors adapted to mate with the proximalconnectors of many different sized implantable stimulation leads. Thecable connector block attaches to a system analyzer and enables thesystem analyzer to interface with whatever implantable stimulation leadsare connected to the connector block, thereby allowing the systemanalyzer to perform desired tests, such as threshold-determining tests,using the implanted stimulation leads.

In accordance with another aspect of the invention, there is alsoprovided an ICD clamp assembly designed to be used with the cableconnector block that permits an in-line electrical connection of theproper polarity to be established between the ICD and the cableconnector block after the implanted leads have been connected to theICD. Advantageously, the ICD clamp assembly includes a clamp that simplyclamps over the ICD and establishes electrical contact with thesetscrews or other securing means used to secure the proximal terminalof the shocking leads to the ICD, thereby providing the desired in-lineelectrical connection without the use of any adapters that require thedisconnecting of the shocking leads from the ICD. Moreover, the clamp isspecially configured so that it can only clamp over the ICD and makecontact with the shocking lead setscrews in one orientation, therebyassuring that the resulting electrical connection is of the properpolarity. The clamp connector of the clamp assembly is electricallyconnected to the connector block through a cable and keyed plug, therebyfurther assuring that the proper polarity is maintained at the cableconnector block. Hence, by simply clamping the clamp over the ICD,plugging the keyed plug of the clamp assembly into the cable connectorblock, and connecting the cable connector block to the system analyzer,the system analyzer can monitor the performance of the ICD including theoutput energy delivered by the ICD without concern for whether a properpolarity connection has been established between the ICD and the systemanalyzer.

It is thus a feature of the present invention to provide a universalconnector block that facilitates the temporary electrical connection ofa set of implanted leads (which set of leads may be of varying sizes andtypes) intended for use with an implantable stimulation device, such asan ICD, with a non-implanted system analyzer, or similar testing device.

It is a further feature of the invention to provide such a universalconnector block that is sterilizable and suitable for use in a medicaloperating room environment.

It is an additional feature of the invention to provide a universalconnector block adapted to connect with a wide variety of differentsizes and types of proximal connectors of implantable stimulation leadsthat does not require the use of setscrews, or equivalent securingmeans, which setscrews or other securing means could possible damage theproximal connectors of the implantable stimulation leads.

It is another feature of the invention to provide a system forconducting preliminary tests on one or more implanted leads, such asthreshold-determining tests or impedance tests, prior to connecting suchimplanted lead or leads to an implantable stimulation device.

It is still an additional feature of the invention to provide aconnection tool for easily and temporarily establishing in-lineelectrical contact of the correct polarity with the output of animplantable stimulation device, as observed or measured on an outputlead or leads connected to the stimulation device, without disturbingthe connection of the one or more implantable stimulation leads from orto the stimulation device. A related feature of the invention is thatsuch connection tool prevents the establishment of an improperelectrical contact, e.g., an electrical contact of the incorrectpolarity.

It is yet a further feature of the invention to provide a universalcable connection block and/or a connection tool as above described thatis suitable for use in a sterile environment, inexpensive to manufactureand distribute, and simple and safe to use.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features and advantages of the presentinvention will become more apparent from the Detailed Description of theInvention in conjunction with the following drawings, wherein:

FIG. 1 shows a block diagram of a system for testing a set ofimplantable stimulation leads adapted for use with an implantablecardioverter-defibrillator (ICD);

FIG. 2 is a wiring diagram of the cable connector used in the system ofFIG. 1;

FIG. 3 is a block diagram of the Defibrillation System Analyzer (DSA)used in the system of FIG. 1;

FIGS. 4, 5 and 6 are top, end and side views, respectively, of apreferred cable connector block made in accordance with the presentinvention;

FIGS. 7 and 8 are partial sectional views taken alone the lines A--A andB--B, respectively, of FIG. 6;

FIG. 9 shows a schematic representation of the preferred embodiment ofthe clamp assembly, including the clamp, the cable, and the keyed plugshown in FIG. 1.

FIG. 10 is an exploded view of an ICD clamp assembly made in accordancewith the present invention;

FIG. 11 is a view as in FIG. 10, but with the jaw and cable elementsrotated 90 degrees;

FIGS. 12, 13 and 14 are a partial back view, a side view, and a frontview, respectively, of an ICD that may be used with the presentinvention; and

FIGS. 15 and 16 illustrate how the ICD clamp assembly is attached to anICD.

Corresponding reference characters indicate corresponding componentsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best mode presently contemplated forcarrying out the invention. This description is not to be taken in alimiting sense, but is made merely for the purpose of describing thegeneral principles of the invention. The scope of the invention shouldbe determined with reference to the claims.

Referring first to FIG. 1, there is shown a block diagram of a system 20for testing a set of implanted leads 22 adapted for use with animplantable stimulation device. For the description that follows, itwill be assumed that the implantable stimulation device comprises animplantable cardioverter-defibrillator (ICD) 24. However, it is to beunderstood that an ICD is only one example of an implantable stimulationdevice, and that the invention has applicability to more than just anICD.

The set of implanted stimulation leads 22 typically includes one or moreendocardial leads that are implanted in a patient so as to contact apatient's heart 26. Shown in PIG. 1, for example, is a bipolar lead 28having a distal tip 29 and a distal ring electrode 30 in contact withthe ventricle of the heart 26. The lead 28 includes a proximal connector38 adapted for connection with the ICD 24. The lead 28 is used to sensenatural contractions of the heart 26 and/or to provide stimulationpulses to the heart 26, i.e., to provide a sensing/pacing function, asrequired by the operation of the ICD, or other implantable stimulationdevice. The proximal connector 38 also typically includes a set ofsealing rings 37 that physically seal the proximal connector into areceiving channel and prevent the ingress of body fluids into thereceiving channel.

It is to be understood that the particular lead configuration shown inFIG. 1 for the sensing/pacing function may also be realized using otherlead configurations, e.g., the bipolar sensing/pacing function could beachieved through two unipolar leads 31 and 32. Electrodes 35 and 36 ofthe leads 31 and 32, respectively, are typically screw-in leads toensure that the electrodes 35 and 36 do not become dislodged during ahigh energy shocking pulse. One of the electrodes 35 or 36 may beconfigured as the cathode (-), while the other electrode acts as theanode (+). Further, it is noted that the leads 28, 31 or 32 may beendocardial leads or epicardial leads and may include active or passivefixation means to hold the distal electrodes in a desired tissuestimulation location.

For purposes of the present invention, the important point to noterelative to the sensing/pacing leads 28 or 31 and 32, regardless of howmany there may be, is that each has a particular proximal connector(e.g., 38, 33 or 34, respectively) of a particular size and type. Thesize of the proximal connector is typically expressed in terms of thediameter of the main part of the connector (the part about which thesealing rings 37 are placed), that is insertable into a receivingchannel of a mating connector of the ICD 24, or other stimulationdevice. Representative sizes of proximal sensing/pacing connectorsinclude 3.2 man and 5 mm. The type of proximal connector will generallybe either a unipolar connector or a bipolar connector. A proximalconnector of a typical unipolar lead has a single conductive male pinthat is sized for insertion into a receiving female connector at thestimulation device. A proximal connector of a typical bipolar lead hasboth a conductive male pin, as does a unipolar lead, and a ringelectrode, spaced-apart a short distance from the male pin but stillnear the proximal end of the lead, both of which are inserted into anappropriate receiving female connector at the stimulation device. Somebipolar leads are split into two branches near the proximal end and havetwo unipolar connectors, one for each branch, and thus appear forconnection purposes, the same as two unipolar leads. The manner offabricating unipolar and bipolar proximal connectors and leads is wellknown in the art. See, e.g., U.S. Pat. Nos. 4,466,441; 4,522,212;4,764,132; 4,791,935; 4,848,346; 5,007,864; and 5,012,807. U.S. Pat.Nos. 4,764,132; 5,007,864; and 5,012,807 are particularly helpfulbecause they detail a typical proximal connector of an implantablestimulation lead, and particular types of connectors used by animplantable stimulation device that interface with such proximalconnectors. The '132, '864, and '807 patents are incorporated herein byreference.

Where the implantable stimulation device comprises an ICD, as shown inFIG. 1, the set of implanted leads also includes shocking leads 40 and42. At the distal end of the shocking leads are suitable electrodes 44and 46 adapted to contact a large tissue area of the heart 26. The mostcommon type of distal electrode used by a shocking lead is a "patch"electrode, although numerous other types of electrodes and electrodeconfigurations and methods of implantation, can and have been used withICDs. See, e.g., U.S. Pat. Nos. 4,727,877; 4,774,952; 4,817,634;4,865,037; 4,991,578; 4,991,603; and 4,998,975. Any of the electrodes orimplantation techniques disclosed in above patents, or other electrodesand implantation techniques and methods, could be used with the presentinvention. In FIG. 1, the electrodes 44 and 46 are shown as being incontact with the right and left ventricles, respectively, of the heart26. It is noted that such electrode placement is only exemplary.

The shocking leads 40 and 42 each have a proximal connector 48 and 50,respectively, adapted to be inserted into an appropriately sizedconnector of the ICD 24. The proximal connectors 48 and 50 alsotypically include sealing rings 37, the same as do the proximalconnectors 33, 34 and 38 of the sensing/pacing leads. Representativesizes of the proximal connectors of shocking leads are 3.2 mm and 6 mm.As with pacing leads, this size represents the diameter of the main partof the proximal male connector (that part about which the sealing rings37 are placed).

Still referring to FIG. 1, the system 20 includes a universal cableconnector block 52 adapted to interface with the set of implanted leads22 so that such leads may be temporarily connected, e.g., during theimplant procedure, with an external, non-implanted defibrillation systemanalyzer (DSA) 54. The cable connector block 52 includes a first set offemale connectors 56 adapted to interface with a plurality of differentsized pacing/sensing leads. The connector block 52 also includes asecond set of female connectors 58 adapted to interface with a pluralityof different sized shocking leads. For the embodiment shown in FIG. 1,the first set of female connectors 56 includes a pair of setscrewless3.2 mm connectors, and a pair of setscrewless 5 mm connectors. Themanner of making a setscrewless female connector is illustrated, e.g.,in U.S. Pat. No. 4,848,346, previously incorporated herein by reference.

Each connector of each sensing/pacing pair of female connectors 56 ispreferably marked with an appropriate polarity symbol, e.g., "+" or "-",to indicate the polarity of the sensing/pacing lead to be insertedtherein. Moreover, in a preferred embodiment, one of the sensing/pacing3.2 mm connectors on the connector block 52 comprises a standard VS-1connector adapted to receive a bipolar VS-1 proximal male connector of abipolar implanted lead. (See Calfee, et al., supra, for the descriptionof a VS-1 connector.) Such a VS-1 connector, or equivalent bipolarconnector, advantageously may double as a unipolar connector when aunipolar lead is inserted therein. When a unipolar sensing/pacing leadis to be inserted into the connector block 52, it is simply insertedinto the connector of the appropriate size and polarity (usually "-")and the other polarity connector of the same pair is not used or isconnected to a temporary return electrode.

Each connector of each shocking pair of female connectors 58 is alsomarked with an appropriate polarity symbol, e.g., "+" or "-", toindicate the polarity of the shocking lead to be inserted therein.

The connector block 52 has a multi-conductor cable 60 attached theretothat electrically connects each of the terminals associated with thefemale connectors of the connector pairs 56 and 58 to designated pins ofa multi-pin connector 62. A wiring diagram that shows the manner inwhich this connection is made is shown in FIG. 2. As seen in FIG. 2, thenegative terminals of the female sensing/pacing connectors 56 ofconnector block 52 are connected to pin 1 of the multi-pin connector 62via a size 24 awg wire conductor 61 within the multi-conductor cable 60.These negative terminals comprise a VS-1 tip terminal 64 and a 5 mm "-"terminal 72. Similarly, the positive terminals of the femalesensing/pacing connectors 56 of the connector block 52 are connected topin 2 of the multi-pin connector 62 via a size 24 awg wire conductor 63within the multi-conductor cable 60. These positive terminals comprise aVS-1 ring terminal 68, a 3.2 mm "+" terminal 70, and a 5 mm "+" terminal66. Likewise, the positive terminals of the defibrillation (or"shocking") connectors 58 of the connector block 52 are connected to pin4 of the multi-pin connector 62 via a size 18 awg wire conductor 65within the multi-conductor cable 60. These positive shocking terminalscomprise a 3.2 mm "+" terminal 74 and a 6 mm "+" terminal 76.Correspondingly, the negative terminals of the shocking connectors 58 ofthe connector block 52 are connected to pin 5 of the multi-pin connector62 via a size 18 awg wire conductor 67 within the multi-conductor cable60. Such negative shocking terminals include a 3.2 mm "-" terminal 78,and a 6 mm "-" terminal 80. A fifth pin, pin 3, of the multi-pinconnector 62 is not used. In this manner, then, all of the terminalsassociated with the connectors 56 and 58 of the connector block 52 areelectrically connected to designated pins of the multi-pin connector 62through at least one of the conductors of the multi-conductor cable 60.

Returning again to PIG. 1, it is seen that the multi-pin connector 62 ofthe cable 60 is adapted to mate with a corresponding connector 82 of theDSA 54. The DSA 54, described more fully below, allows desired tests ortest signals to be applied to the implanted leads 22 via the cable 60and connector block 52 when the leads 22 are connected to theappropriately sized connectors 56 and/or 58 of the connector block 52.The DSA 54 applies the desired tests or test signals to the leads 22 ascontrolled by a control panel 84. As required, appropriate peripheraldevices, such as a battery charger 86, a printer 88, and/or a pacingsystem analyzer (PSA) 90, are connected to the DSA in order tofacilitate the tests that are carried out.

As further seen in FIG. 1, in accordance with one aspect of theinvention, there is provided an ICD clamp assembly 92 that permits theDSA 82 to monitor the operation of the ICD after the shocking leads 40and 42 have been connected to the ICD 24 through receiving channels 89and 91, respectively. As detailed below in connection with thedescription of FIGS. 9-16, the clamp assembly 92 includes a clamp 94, acable 96, and a keyed plug 98. The clamp 94, shown in more detail inFIGS. 10-11 and 15-16, is configured to clamp over that portion of theICD 24 where the shocking leads 40 and 42 attach. Contact pins withinthe clamp 94 make contact with conductive connection elements, e.g.,setscrews, used by the ICD 24 in making a secure electrical andmechanical connection with the leads 40 and 42. Thus, in-line electricalconnection is established with the leads 40 and 42 while they areconnected to the ICD and while the ICD is performing its desiredfunction. Further, the clamp is shaped so that it can only clamp overthe ICD 24 in one orientation, and hence it is only possible for a givencontact pin within the clamp 94 to make electrical contact with a givenlead, thereby preserving a desired polarity of the established in-lineelectrical connection. The electrical contact thus established iscarried to the plug 98 by way of the cable 96. The plug 98 is keyed andadapted to be inserted into a pair of the shocking female connectors 58of the connector block 52 in only one orientation, thereby furtherpreserving the desired polarity of the electrical connection. Hence,when the plug 98 is inserted into the connector block 52, the DSA isable to confirm the proper operation of the ICD 24 while the ICD isoperating, but before the implant operation is concluded. For example,the in-line connection established by the clamp assembly 92 allows theDSA to monitor the actual output energy delivered by the ICD 24 to thepatient through the shocking leads (48, 50), a measurement which wouldotherwise be impossible without establishing an appropriate in-lineconnection.

For purposes of the present invention, the details of the DSA 54 are notcritical. Any suitable analyzer or equivalent test apparatus designed totest the implanted leads 22 and/or an implantable stimulation device towhich the leads are connected, could be used. Representative analyzersystems are disclosed, for example, in U.S. Pat. Nos. 4,476,869 and4,809,697. Such systems, with minor or no modification, could be used asthe DSA 54 and/or the PSA 90. The '697 patent is incorporated herein byreference.

A block diagram of one configuration of the DSA 54 is shown in FIG. 3.The DSA includes a microcontroller 100 that interfaces with and controlstwo defibrillators, a conventional defibrillator 102 and an emergencydefibrillator 104. Also, the microcontroller 100 controls a fibrillator106. Appropriate manual controls, e.g., pushbutton switches, foroperating the DSA 54, are provided on the control panel 84. Themicrocontroller is programmed to perform the functions of adefibrillator and a means to induce fibrillation. The defibrillator 102comprises an adjustable output, programmable defibrillator that iscontrolled to deliver user-defined shocks either synchronous with thedetection of a QRS complex or asynchronously. (A QRS complex occurs whenthe ventricles of the heart depolarize and contract.) The emergencydefibrillator 104 comprises a fixed output defibrillator that deliversfixed 40 joule shocks either synchronously with the QRS detection orasynchronously. Both defibrillators 102 and 104 may be of conventionaldesign. The emergency defibrillator 104 is designed so that it can be ina ready state within 6 seconds after the DSA is first powered up or anemergency shock is delivered. The outputs of both defibrillators areconnected to the shocking electrodes through the connector block 52.

Included within the control panel 84 is a display 85. Such display isused to display such parameters as the measured lead impedance, thepredicted energy of the defibrillation shock, the delivered energy ofthe defibrillation shock, or the status (voltage) of the batteries.

Should the DSA 54 be powered down (turned off), the energy stored in thedefibrillators 102 and 104 is discharged internal to the DSA, therebypreventing the possibility of an inadvertent external shock. Further, atany time, a user of the DSA can discharge the defibrillators by pressinga button on the DSA front panel.

An appropriate sense amplifier 108 is coupled to the sensing/pacingleads through the connector block 52 to sense cardiac activity, e.g.,the occurrence of a QRS complex (evidencing contraction of theventricles) of the heart. An audio alarm 110 generates an audio alarmupon the occurrence or non-occurrence of specified events, e.g., uponfailure to detect a QRS complex at a regular rate.

Also included within the DSA 54 is a battery 112 to which the batterycharger 86 (FIG. 1) is coupled. A sense/test circuit 114 allows thestatus of the battery to be checked under control of the microcontroller100. Further, a switch mode power supply 116 drawing energy from thebattery 112 provides the needed operating power for all but the highvoltage circuits of the DSA. An isolated power supply 118 also drawingits operating energy from the battery 112 is used to provide the powerneeded by the high voltage (defibrillation) circuits of the DSA. Thebattery 114 comprises a single 6-volt sealed lead acid battery.

The DSA 54 thus provides three main functions: (1) it measures variousparameters associated with the implanted leads, e.g., lead impedance;(2) it fibrillates the heart; and (3) after induced fibrillation, itattempts to defibrillate the heart using a defibrillation shock of aspecific energy. If the heart is not successfully defibrillated at oneenergy, then the energy is increased until it is defibrillated. In thisway, the defibrillation threshold is measured, thus limiting damage tothe heart tissue, and the performance of the ICD is verified.

Fibrillation is induced by the fibrillator 106 upon the momentarydepressing of a FIBRILLATE pushbutton on the control panel 84.Fibrillation is induced by applying an AC voltage having a programmablemagnitude of 2, 4, 6 or 8 VAC (rms) to the heart through the shockingleads 40 and 42 (FIG. 1). To confirm the presence of the AC signal onthe patch electrodes, the audio alarm beeps repetitively.

The defibrillator 102 provides shocking pulses having programmablewidths and amplitudes (i.e., programmable output energies) as selectedby pushbuttons located on the control panel 84. The available outputpulse energies include 0.5, 1, 2, 5, 7, 10, 15, 20, 30 or 40 joules. Theoutput pulse widths may be selected to be 2, 4, 6, 7.8, 8 or 10 ms. Theoutput delay is 30 ms, which means that the output energy is deliveredto the patch electrodes (after pressing the DELIVER button) 30 ms aftera QRS complex is detected, or 0.5 ms after the DELIVER button is pressedif no QRS complex is detected. A CHARGE switch is pressed to begincharging the defibrillator capacitors used within the defibrillatorcircuits. An LED (light-emitting diode) illuminates to confirm thatcharging is in process. When the programmed charge is obtained, anotherLED illuminates, indicating that a DELIVER switch may then be pressed todeliver the programmed shock to the patch electrodes.

The microcontroller 100, in the preferred embodiment, utilizes a statemachine architecture. Three state machines are implemented to controlthe operations of the DSA: a Defib/Fib State Machine, an EDEFIB(emergency defibrillation) Control State Machine, and an LED DisplayControl State Machine. The three state machines operate independent ofeach other in order to carry out their designated functions. Other statemachines are added, as desired or required, to perform other testfunctions. All of the state machines may be implemented in software.

It is again emphasized that the details of a particular DSA design arenot needed in order to practice the present invention. Hence, suchdetails are not presented herein. It is submitted that those of skill inthe art, given the descriptions presented herein, can readily fashion anappropriate DSA, or equivalent, for use with the present invention inorder to test a set of implanted stimulation leads and/or implantablestimulation device connected to such leads.

To momentarily summarize, it is seen that one embodiment of theinvention, as described thus far in connection with FIGS. 1-3, may becharacterized as a system 20 for testing a set of implanted stimulationleads adapted for use with an implantable stimulation device 24. Suchsystem includes a non-implantable analyzer 54 having a first multi-pinconnector 82. The analyzer includes processing means 100 for applyingtest signals to and monitoring test signals on specified pins of thefirst multi-pin connector in accordance with a prescribed test sequence.The system further includes a first plurality of implantable stimulationleads 22 for use with the implantable stimulation device, with eachhaving a proximal connector (34, 38, 48, 50) of a prescribed sizeadapted to be detachably secured to the implantable stimulation device.Also included in the system is a cable connector block 52 having asecond plurality of connectors (56 and 58), with the proximal connectorof each of the first plurality of implantable stimulation leads beingdetachably securable to one of the second plurality of connectors.Advantageously, the second plurality is greater than the first plurality(i.e., there are some connectors in the cable connector block that arenot used), thereby allowing the second plurality of connectors toinclude a variation of sizes adapted to receive a correspondingvariation of different size proximal connectors. Thus, a versatile cableconnector block is provided that "fits all" (or at least most all)implantable stimulation₋₋ leads.

Still summarizing, it is seen that the system 20 (FIG. 1) includes amulti-conductor cable 60 connected (either physically secured ordetachably secured) at a first end to the cable connector block 52 and asecond end attached to a second multi-pin connector 62. The secondmulti-pin connector is adapted to mate with the first multi-pinconnector 82 of the analyzer. The multi-conductor cable has amultiplicity of electrical conductors (FIG. 2) therein (61, 63, 65, 67),with each connector of the cable connector block being connected to arespective pin of the second multi-pin connector through at least one ofthe multiplicity of electrical conductors.

Hence, the system 20 allows each of the implantable stimulation leads tobe detachably connected to one of the respective pins of the secondmulti-pin connector whenever such implantable stimulation lead isdetachably secured to a corresponding connector-of the cable connectorblock. In this way, use of the cable connector block 52 allows thesystem analyzer 54 to apply a desired test signal to the implantablestimulation lead or to monitor a signal appearing on the implantablestimulation lead, in accordance with the prescribed test sequence. Thus,a particular configuration of the plurality of implantable stimulationleads may be readily tested, e.g., in order to determine a thresholdlevel prior to connecting the implantable stimulation leads to theimplantable stimulation device.

In FIGS. 4, 5 and 6, there are shown top, end, and side views,respectively, of a preferred cable connector block 52 that may be usedwith the system 20 described above. In the description that follows,reference should also be made to FIGS. 7 and 8, which show sectionalviews taken along the lines A--A and B--B, respectively, of FIG. 6. Asseen in FIGS. 4-6, an inner housing 120 provides structural support forthe various terminals 64-80 (see also FIG. 2) used as part of theconnectors 56 and 58. Such terminals are setscrewless terminals as areknown in the art. The inner housing 120 also serves as a chamber orjunction box wherein the various electrical wire conductors of the cable60 are housed as they are physically and electrically connected to theterminals 64--80. An appropriate label 122 is affixed to the innerhousing 120 in order to identify the terminals 64-80 as to type, e.g.,SENSING/PACING or SHOCKING, and with an appropriate size and polarity,e.g., 3.2 mm "-". If the multi-conductor cable 60 is to be physicallysecured at the first end of the body block 150, a strain relief may beprovided at location 124 that secures the cable to the inner housing120. If the multi-conductor cable 60 is to be detachably secured to thebody block 150, a multi-pin connector arrangement would be incorporatedat location 124 similar to the first and second multi-pin connector atthe system analyzer and the second end of the multi-conductor cable 60,respectively. The advantage of making the body block completelydetachable is that it may be desirable to sterilize only themulticonductor cable 60 and simply dispose of the body block 150.

Once assembled, the inner housing 120 is placed in a suitable mold andis encapsulated (e.g., through an injection-molding process) with asuitable nonconductive transparent PVC to form the thick body block 150.As part of the molding or finishing process, appropriately sizedreceiving channels 126, 128, 130, 132, 134, 136, 138 and 140 are moldedand/or machined into the resulting body block 150 in order to providephysical access to the terminals 64-80. Such receiving channels have across-sectional shape (best seen in FIGS. 7 and 8) adapted to receivethe proximal male connectors of the different sized pacing or shockingleads that may be encountered. As part of this molding and/or finishingprocess, a keyed channel 142 is also placed in the body block 150between the channels 134 and 136. This keyed channel 142 is offsetbetween the channels 134 and 136. In combination, the channels 134, 142and 136 provide a keyed female connector 154 (best seen in FIG. 6) intowhich prongs 144, 148 and 146 of plug 98 (FIG. 1) may be received inonly one orientation. Further, as part of the molding and/or finishingprocess, a suitable ring electrode 152 (best seen in the sectional viewof FIG. 7, but also shown in FIG. 4) is positioned within the VS-1channel 126 and connected to the ring electrode terminal 68 with a wireconnection 156.

Thus, as described above in FIGS. 1, 2 and 4-8, it is seen that thepresent invention further includes a universal cable connector block 52for detachably connecting a plurality of implanted leads used with animplantable stimulation device to a system analyzer. The universal cableconnector block 52 includes: (1) a nonconductive body block 150; (2) aplurality of electrical terminals (64-80, 152) mounted within the bodyblock; and (3) a multi-conductor cable 60 connecting the plurality ofelectrical connectors to a multi-pin connector 62. The plurality ofelectrical terminals (64-80, 152) mounted within the body block 150 aremounted in a spaced-apart relationship, and, in combination withappropriately sized receiving channels 126-140, comprises the two setsof female connectors 56 and 58. Each connector of the body block isadapted to detachably connect with a male proximal connector of the sameprescribed size. Advantageously, at least a plurality of differentprescribed size electrical connectors are included within the pluralityof electrical connectors, thereby facilitating the attachment of aplurality of different size electrical connectors to the body block. Themulti-conductor insulated cable has a first end either physicallysecured or detachably secured to the body block and a second endattached to a multi-pin connector for detachable₋₋ connection with amulti-pin connector in the system analyzer. A plurality of conductorsare included within the multi-conductor cable, each being electricallyinsulated from the others. Each one of the spaced-apart electricalconnectors of the body block has at least one of the plurality ofconductors electrically connected thereto. Further, the multi-pinconnector has a plurality of contact pins to which at least one of theplurality of conductors within the multi-conductor cable is electricallyconnected. The multi-pin connector may then be detachably secured to thesystem analyzer. Thus, using such universal cable connector, at leastone implantable stimulation lead having a proximal connector of the samesize as one of the plurality of electrical connectors within thenonconductive body block may be detachably secured to the same sizeconnector, and the multi-pin connector may be detachably secured to thesystem analyzer, thereby temporarily connecting at least one implantablestimulation lead to the system analyzer.

Next, turning to FIGS. 9, 10 and 11, a preferred embodiment of the clampassembly 92 is illustrated. FIG. 9 shows a schematic representation ofthe entire assembly 92, which includes a clamp 94, a cable 96, and akeyed plug 98. The cable 96 is a conventional multi-conductor cablehaving at least a plurality of insulated conductors (wires) therein.Such conductors are split at a junction point 97 into two branches 160and 162 near the clamp end of the cable. The branch 160 is electricallyconnected to a first contact pin 164 within the clamp 94, and the branch162 is similarly connected to a second contact pin 166 opposite thecontact pin 164 within the clamp 94.

The construction of the clamp 94 is best seen in the exploded views ofFIGS. 10 and 11. FIG. 10 shows an exploded side view of the clamp 94,including the cable branches 160 and 162 and contact pins 164 and 166.FIG. 11 shows an exploded view as in FIG. 10, but with the jaw and cableelements rotated 90 degrees. As seen in FIGS. 10 and 11, the clamp 92includes a set of nonconductive movable jaws 168 and 170 connected to apivot point 172 for opening and closing. A spring 174 is mounted withinthe set of movable jaws centered about the pivot point 172 so as toapply a spring force that tends to close the jaws. The jaw 168 has ahandle 176 that extends out from the pivot point 172, and the jaw 170similarly has a handle 178. The handles 176 and 178 provide a means formanually opening the set of jaws by applying a manual force that opposesthe spring force. The tips of the jaws 168 and 170 include respectiveend plates 180 and 182. The end plates 180 and 182, in combination witha bend in the jaws (seen best in FIG. 11), restrict the placement of theclamp over the ICD to just one orientation.

The contact pins 164 and 166 are mounted in respective nonconductivepedestals 184 and 186 that protrude out from base units 188 and 190. Thepedestals 184, 186 and base units 188, 190 are preferably moldedcomponents made from nonconductive plastic or rubber, thereby formingone integral component for holding each contact pin. The base units 188,190 have a specific shape (best seen in FIG. 11) that restricts theirinsertion into only one of similarly shaped recesses 192, 194 within thejaws 168 and 170.

The pivot point 172 is realized by short axle stubs 196 that extend outfrom both sides of the jaw 168 and are adapted to be received incorresponding slots 198 that extend out from both sides of the jaw 170.Appropriate rib structure 200, 202 is placed on the underneath side ofthe jaws 168 and 170, in order to add structural strength to the jawsand clamp. Advantageously, all of the components of the clamp assemblymay be inexpensively made using injection molding or equivalenttechniques, and all can be readily and easily assembled to form theclamp assembly 92.

As evident from FIGS. 10 and 11, the contact pins 164 and 166, or morespecifically, the integral base units 188 and 190 (which hold the pinson their respective pedestals 184 and 186), are positioned within therespective recesses 192 and 194 of the jaws 168 and 170 so that when theclamp is assembled, the contact pins face each other, as seen best inFIG. 9.

The positioning of the contact pins 164 and 166 allows the pins to makeelectrical contact with the conductive element used to secure the leadsto an implantable stimulation device, e.g., the ICD 24 (FIG. 1), whenthe set of jaws are closed over the implantable stimulation device. Theconductive element typically comprises a setscrew, as described morefully below in FIGS. 12-16. The electrical contact is thereaftermaintained by the spring force provided by the spring 174. Suchelectrical contact thus establishes an in-line electrical connectionwith the leads attached to the ICD.

The cable 96 has a plurality of electrical conductors therein that makerespective electrical contact with the contact pins 164 and 166. Theplug 98 is attached to the end of the cable 96 opposite the endconnected to the contact pins 164, 166. The plug 98, as described above,includes a plurality of prongs 144, 146 and 148 that are keyed forinsertion into a mating connector of the connector block 52 in only oneorientation. Thus, by clamping the clamp over the ICD which can only bedone in one orientation, the contact pins make respective electricalcontact with specific leads attached to the ICD. That is, one contactpin makes contact with a positive lead, and the other contact pin makescontact with a negative lead. Such polarity-maintained contact is thentransferred to the system analyzer 54 when the keyed plug 98 is insertedinto the block connector 52.

In FIGS. 12-14, back, side and front views of a typical ICD 24 areillustrated. In one corner of the ICD is a lead header block 200,fabricated in the same manner as are the header blocks used withimplantable pacemakers. It is the function of the header block 200 toreceive the proximal male connectors of the implantable stimulationleads. To this end, the ICD 24 includes two channels 202 and 204 forreceiving the proximal male connectors 36 and 38 of the sensing/pacingleads 28 and 32 (see FIG. 1); and two channels 206 and 208 for receivingthe proximal male connectors 48 and 50 of the shocking leads 40 and 42.Located within these receiving channels is an appropriate electrode towhich a setscrew is threadably attached. When the proximal maleconnector of the lead is inserted into the receiving channel so as tocontact the electrode therein, the setscrew is tightened, therebysecurely locking the male connector to the electrode and ensuring a goodelectrical connection. A setscrew 210, for example, is used within theshocking lead receiving channel 206; and a setscrew 212 is used withinthe shocking lead receiving channel 208. Such setscrews are off-axisfrom the channel axis. That is, if the channel axis of the channel 206is represented by the dashed line 214 (which channel axis represents thelongitudinal direction of the channel, and hence the direction in whichthe proximal connector of the lead is inserted into the channel), thenthe setscrew, when adjusted, moves in and out in a direction that isnon-parallel, e.g., perpendicular, to the channel axis. Other setscrewsare used, as required, to secure the sensing/pacing leads in theirrespective channels.

The heads of the setscrews are accessible through appropriate openings,or set-screw access channels, in the header block. For example, the headof the setscrew 210 is accessed through an opening 216; and the head ofthe setscrew 212 is accessed through an opening 218. Other openings 220,222 and 224 of a smaller diameter than the openings 216 and 218, areused to access other setscrews used in the channels 202 and 204. If theimplantable stimulation device is an ICD, the size of the pedestals 184and 186 (used to hold the contact pins 164 and 166 of the clamp 94) isselected to fit within the set-screw access channels 216 and 218 (usedfor the shocking leads), but not within the smaller set-screw accesschannels 220, 222 and 224 used for the sensing/pacing leads. Hence, whenthe clamp assembly 92 is attached to the ICD 24, electrical contact canonly be made with the setscrews 210 and 212 used to secure the shockingleads to the ICD.

It is understood, however, that a plurality of pedestals of varyingsizes could be employed to make contact with all the set-screw accesschannels (e.g., 216, 218, 220, 222 and 224) so that pacing, sensing anddefibrillation functions could be tested by the system analyzer 54.Alternatively, if the implantable stimulation device is simply apacemaker, the size of the pedestals 184 and 186 (used to hold thecontact pins 164 and 166 of the clamp 94) would be selected to fitwithin the set-screw access channels (e.g., 220, 222 and 224) used forthe sensing/pacing leads.

The manner of securing the clamp assembly 92 to the ICD 24 is furtherillustrated in FIGS. 15 and 16. After the implanted leads have beensecured to the ICD 24 (which leads are not shown in FIGS. 15 and 16; butwhich leads attach to the receiving channels 206 and 208), the clamp 94of the clamp assembly 92 is grasped firmly with one hand, as shown inFIG. 15, while holding the ICD with the other hand. The clamp 94 is thenopened so that it fits over the header block 200 of the ICD. The bend inthe jaws of the clamp, as well as the end plates 180 and 182 at the endof the jaws, restricts the placement of the clamp over the header blockto just one orientation, which one orientation assures that a desiredpolarity is maintained. The pedestals holding the contact pins on eachside of the clamp jaws are aligned with the set-screw access channels216 and 218 and the clamp is released. The spring force thus closes theclamp and snaps the contact pins 164 and 166 against the heads of thesetscrews 210 and 212. The clamp 94 is then rotated, as required, untilthe end plates 180 and 182 lie firmly against the side of the ICD, asseen in FIG. 16. The keyed plug 98 is then inserted into the connectorblock 52, thereby establishing an in-line electrical connection of theproper polarity with the shocking leads (48, 50) and electrodes (44, 46,respectively).

In use, the universal cable connector block 52, with its connectingcable 60 and multi-pin connector 62, are sterilized and packaged in asterile shipping container which need not be opened until the connectorblock is inside the operating room where the implant procedure is beingperformed. Similarly, the clamp assembly 92 may be sterilized andpackaged in another sterile shipping container. After being used for onepatient, the connector block and clamp may be resterilized using ETO(ethylenetrioxide) and packaged for use in a subsequent operation. Suchresterilization may be performed by returning the connector block andclamp to the manufacturer, or by the hospital or other medical facilitycapable of performing an ETO sterilizing procedure. In anotherembodiment, the connecting block 52 is detachable from the connectingcable 60 so that the connector block 52 may be disposable.

Thus, as described above, it is seen that the present invention providesa universal connector block that facilitates the temporary electricalconnection of a set of implanted leads (which set of leads may be ofvarying sizes and types) intended for use with an implantablestimulation device, such as an ICD, with a non-implanted systemanalyzer, or similar testing device.

As further described above, it is seen that the invention provides sucha universal connector block that is sterilizable and suitable for use ina medical operating room environment. Moreover, it is seen that theuniversal connector block provided by the invention quickly connectswith a wide variety of different sizes and types of proximal connectorsof implantable stimulation leads without the use of setscrews in theconnector block, which setscrews could possibly damage the proximalconnectors and render the implantable stimulation leads unsuitable.

Also, it is seen from the above description that the invention providesa system for conducting preliminary tests on one or more implantedstimulation leads, such as threshold-determining tests or impedancetests, prior to connecting such implanted stimulation lead or leads toan implantable stimulation device.

Finally, as described above, it is seen that the invention provides aconnection tool for easily and temporarily establishing in-lineelectrical contact of the correct polarity with the output of animplanted stimulation device, as observed or measured on an output leador leads connected to the stimulation device, without disturbing theconnection of the one or more implantable stimulation leads from or tothe stimulation device. Moreover, such connection tool prevents animproper electrical contact, e.g., of the incorrect polarity, with theoutput of the implanted stimulation device.

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modificationsand variations could be made thereto by those skilled in the art withoutdeparting from the scope of the invention set forth in the claims.

What is claimed is:
 1. A universal cable connector for detachablyconnecting a plurality of implanted stimulation leads and an implantablestimulation device to a system analyzer, the cable connectorcomprising:a nonconductive body block; a plurality of electricalconnectors mounted within the body block in a spaced-apart relationship,each of the plurality of electrical connectors having a prescribed size,and each being adapted to detachably connect with a mating electricalconnector of the same prescribed size, at least a plurality of differentprescribed size electrical connectors being included within theplurality of electrical connectors; and a multi-conductor insulatedcable having a plurality of conductors therein that are electricallyinsulated from each other, each of the plurality of conductors beingconnected at one end to at least one of the plurality of electricalconnectors in the body block, the multi-conductor cable has at a secondend a multi-pin connector attached thereto, the multi-pin connectorhaving a plurality of contact pins, each contact pin having at least oneof the plurality of conductors within the multi-conductor cableelectrically connected thereto, the multi-pin connector being adaptedfor detachable securement to the system analyzer; whereby at least oneimplantable stimulation lead having a proximal connector of the samesize as one of the plurality of electrical connectors within thenonconductive body block may be detachably secured to the same-sizeconnector, and the multi-pin connector may be detachably secured to thesystem analyzer, thereby temporarily connecting at least one implantablestimulation lead to the system analyzer.
 2. The cable connector, as setforth in claim 1, wherein the body block is made from materials that aresterilizable.
 3. The cable connector, as set forth in claim 1, whereinthe body block is detachable from the multi-conductor cable.
 4. Thecable connector, as set forth claim 3, wherein the body block isdisposable.
 5. The cable connector, as set forth in claim 1, wherein themulti-conductor cable is made from materials that are sterilizable. 6.The cable connector, as set forth in claim 1, wherein the plurality ofconnectors of the body block are setscrewless connectors.
 7. The cableconnector, as set forth in claim 1, wherein the body block comprisestransparent plastic.
 8. The cable connector, as set forth in claim 1,wherein the body block comprises transparent PVC.
 9. The cableconnector, as set forth in claim 1, wherein the plurality of connectorsinclude at least one pair of connectors from each of the sizes 3.2 mm, 5mm and 6 mm.
 10. The cable connector, as set forth in claim 1, whereinthe plurality of connectors include a pair of 3.2 mm sensing/pacingconnectors for attachment with sensing/pacing leads having a 3.2 mmproximal connector, a pair of 5 mm sensing/pacing connectors forattachment with sensing/pacing leads having a 5 mm proximal connector, apair of 3.2 mm shocking connectors for attachment with shocking leadshaving a 3.2 mm proximal connector, and a pair of 6 mm shockingconnectors for attachment with shocking leads having a 6 mm proximalconnector.
 11. The cable connector, as set forth in claim 1, wherein atleast one of the plurality of connectors of the body block comprises abipolar female connector adapted to connect to either a unipolar orbipolar male proximal connector of a unipolar or bipolar implanted lead,respectively.
 12. The cable connector, as set forth in claim 1,wherein:the plurality of connectors includes first and second connectorsof a specified size spaced-apart a prescribed distance on the bodyblock; and the body block further including an alignment port that is adifferent distance from the first connector than from the secondconnector; whereby the first and second connectors and the alignmentport comprise a keyed configuration to which an appropriately keyedconnector may be attached in only one orientation.
 13. The cableconnector as set forth in claim 1, further comprising:a connecting cablehaving a keyed connector at one end thereof configured for attachment tothe keyed configuration on the body block; a clamp adapted to clamp overthe implantable stimulation device in a prescribed orientation so thatthe connecting cable makes electrical contact with at least a pluralityof the implanted stimulation leads connected to the implantablestimulation device; whereby the plurality of implanted leads may bemonitored by the system analyzer through the clamp assembly and bodyblock for test purposes without having to detach the plurality ofimplanted leads from the implantable stimulation device.
 14. The cableconnector, as set forth in claim 1, wherein the plurality of electricalconnectors in the body block are adapted to receive a variety ofdifferent sized sensing/pacing leads.
 15. The cable connector, as setforth in claim 1, wherein the plurality of electrical connectors in thebody block are adapted to receive a variety of different sized shockingleads.